Informed Consent

Macmillan Encyclopedia of Death and Dying
COPYRIGHT 2002 The Gale Group Inc.

Informed Consent

Twenty-five hundred years of Western medicine, starting with Hippocrates, have been built on the preferred conception that physicians should protect their patients from information about their diseases or treatment options. The oath that has been repeated by physicians for thousands of years articulates clearly that the physician knows what is best for his or her patients. For over two millennia, the culture has put the physician in an almost Godlike position in terms of his or her wisdom to practice in the patient's best interest. However, since the mid-twentieth century there has been a trend toward patients rights, that has included the right to know what the physician intends to do and why. This is the essence of informed consent.

The Emergence of Informed Consent

In one form or another, the question of who gets to decide beats at the heart of the most difficult medical situations. Will it be the physician, the patient, or the family members? Whose values will ultimately be respected? What should a patient be told regarding the range of complicated life and death decisions commonplace in today's medical arena?

The definition of informed consent is equally complicated. An informed consent is an autonomous authorization by an individual regarding a medical intervention or involvement in biomedical research. An individual must do more than express agreement or comply with a proposal for this to be considered informed consent. Informed consent is a process between physician and patient that must contain an information component and a consent component. The information component refers to the disclosure of information and comprehension of what is disclosed. The consent component refers to a voluntary decision and agreement to undergo a recommended procedure. Legal, regulatory, philosophical, medical, and psychological literature tend to favor the following elements as the necessary components of informed consent: (1) competence; (2) disclosure; (3) understanding; (4) voluntariness; and (5) consent.

If one is competent to act, receives thorough disclosure, has an understanding, and is voluntary in his or her consent, then informed consent is viable. For informed consent to be legally recognized in medical practice, the following steps need to be clearly articulated:

Physicians are obligated to disclose a core set of information including: (1) those facts or descriptions that patients usually consider material in deciding whether to refuse or consent to the proposed intervention; (2) information that the physician thinks is critical; (3) the professionals' recommendation; (4) the purpose of seeking consent; and (5) the nature and limits of consent as an act of authorization.

History of Informed Consent within Medical Practice

Civil litigation emerged over informed consent to include injury to one's person or property that is intentionally or negligently inflicted by a physician's failure to disclose the injury, measured in terms of monetary damages. With the medical advances that emerged in the beginning of the twentieth century, such as improved anesthesia and surgical interventions, physicians began to disclose basic information without necessarily outlining all potential risks.

The first important introduction of the notion of informed consent is in the classic case of Mohr v. Williams (1905). In this case, a physician obtained Anna Mohr's consent to an operation on her right ear. While operating, the surgeon determined that the left ear needed surgery instead, and proceeded to operate on it. A court found that the physician should have obtained the patient's consent to the surgery on the left ear. The judge decided that a physician needs to advise a patient of all the information related to a particular procedure and must review all the risks and benefits. Only after this exchange does the patient enter into a contract, a contract that authorizes the physician to operate only to the extent of the consent given.

In the late 1950s a series of legal cases in California and the District of Columbia forever changed society's vision of the doctor-patient relationship. In California, radiation therapy went awry for a young woman, leaving her in much worse condition than prior to the treatment. After the therapy she was acutely fatigued and suffering from radiation burns. These side effects far exceeded the side effects described by the physician. She sued the physician, saying he never adequately explained the risks of her radiation procedure. The court found that unless such consent was based on full information, and that the patient fully understood all of the risks of the procedure, the doctor was not protected for liability. In several jurisdictions, beginning in 1972 in the District of Columbia, Canterbury v. Spence, informed consent emerged as a legal right with full legal redress equivalent to battery if informed consent was not provided.

With the mid-1970s came the introduction and growing utilization of extraordinary life-sustaining treatments such as dialysis, respirators, cardiac resuscitation, and a wide array of organ transplantation. To protect oneself from the automatic use of such heroic measures, patients and their family members experienced an urgent need to be fully informed of risks and benefits and to have the authority to protect their wishes. Legal methods, including advance directives, living wills, and health care proxies, came to the fore of patient's rights as mechanisms to articulate and protect the
patient's wishes over the imperative central tenet to medicine: If it can be done, it should be done.

Advance directives. The Patient Self-Determination Act (PSDA) was passed in 1990 and went into effect in December 1991. The essence of this legislation is to empower the public with the right to be fully informed and fully self-determining regarding end-of-life decisions. However, since its implementation there is little evidence of national acceptance by the health care industry. The law applies to all health care facilities that receive any federal reimbursement for services, and includes hospitals, nursing homes, home health agencies, and clinics. The PSDA requires a health care mechanism for disseminating information about advance directives with patients.

Advance directives have been available in parts of the United States since the late 1980s, but research shows that only a small percentage (5% to 25%) have some form of written advance directive. Advance directives allow a competent person to express who should be a decision maker and what preferences the patient may have.

Psychiatric advance directives are a legal means by which a person with mental illness, while competent to make health care decisions, may specify his or her preferences for treatment and may designate a surrogate decision maker to act on his or her behalf in the event of an incapacitating mental health crisis.

When informed consent is not viable for the patient, and he or she does not have advance directives, the process of surrogate decision making is initiated. Surrogate decision making refers to the process in which a loved one has to make a medical decision because the patient's judgment is incapacitated. Surrogate decision makers reach decisions for those with fluctuating decisionmaking capacity that is doubtful and thus need to be aware of all the side effects in order to make decisions on behalf of someone else.

Courts and legislatures have been actively involved in the right of surrogate decision makers and the various related ethical dilemmas. Within the context of advanced life-sustaining treatments, patients and their family members have been confronted with life and death choices. The questions regarding who is competent to make which decisions is still a much-litigated scenario. Many judgments about terminating or continuing treatment are made daily for patients who are no longer able to choose for themselves—patients with HIV (human immunodeficiency virus), Alzheimer's disease, and Parkinson's disease, and those suffering from stroke effects, heart and kidney failure, dementia, and psychosis.

History of Informed Consent within Biomedical Research

A comprehensive movement toward informed consent began after World War II with the 1947 Nuremberg trials. In these war trials, it was revealed that physicians conducted abhorrent medical research experiments on concentration camp prisoners. The research included human experimentation with germ warfare, freezing individuals to learn what temperature kills individuals most effectively, and many more horrifying research trials. Between 1930 and 1945 Japan conducted human experimentation in biological warfare, including physical responses to infection and trauma, and thousands were killed. The Nuremberg Code, which emerged from the trials, abandons the earlier paternalistic perspective of medicine and research and replaces it with the centrality of patient self-determination by asserting that the voluntary consent of the human subject is necessary under all circumstances of medical research. With this, the modern era of ethics within biomedical research emerged with a particular emphasis on the patient's rights expressed by the practice of informed consent.

The term informed consent first received wide awareness and prominence in public health research, as well as in the practice of medicine, in 1972, in response to the public outcry regarding unethical practices in the Tuskegee research. In 1932 the U.S. Public Health Service initiated a study that examined the effects of untreated syphilis among rural black men in Tuskegee, Alabama. Thousands of men were kept in total ignorance of the experiment, their infection, and the seriousness of syphilis. They were consistently steered away from receiving effective treatment so the United States government could monitor how the disease progressed, its many serious side effects, and its rate of fatality.

Immediately following this disclosure, the first national government commission, the National Commission for the Protection of Human Subjects
of Biomedical Research and Behavioral Research was established. One of its primary goals was to initiate a variety of legislation to further ensure a patient's right to be fully informed regarding any medical research. A decade later, the President's Commission on the Study of Ethical Problems in Medicine and Biomedical Research and Behavioral Research was formed in 1983 to replace the first commission. Its mandate was to deal with the full range of medical and ethical issues, including the care of the dying, genetics, and issues of health care decisions such as informed consent and allocation of resources.

Informed Consent in the Managed Care Climate

With the era of cost-containment in the 1980s and managed care in the 1990s, informed consent became even more critical. Informed decision counseling (IDC) has been used to promote cost-effective care and provide over-the-phone medical information from twenty-four-hour-a-day clinicians. Designed to promote appropriate utilization and effective patient-provider communication, IDC is based on the premise that health care consumers make appropriate utilization decisions if adequately informed.

Informed consent will continue to evolve in response to continued advances in medical treatment, the shift toward partnership in patient-physician relationships, and new avenues of biomedical research. At the center of informed consent remains the critical primacy of the right for a patient to understand any medical treatment, medical procedure, or participation in medical research.

Gostin, Lawrence. "Deciding Life and Death in the Courtroom: From Quinlan to Cruzan, Glucksberg and Vacco—A Brief History and Analysis of Constitutional Protection of the 'Right to Die.'" Journal of the American Medical Association 278, no. 18 (1997):1523–1528.

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Informed Consent

Gale Encyclopedia of Surgery: A Guide for Patients and Caregivers
COPYRIGHT 2004 The Gale Group Inc.

Informed consent

Definition

Informed consent is a legal document in all 50 states. It is an agreement for a proposed medical treatment or non-treatment, or for a proposed invasive procedure. It requires physicians to disclose the benefits, risks, and alternatives to the proposed treatment, non-treatment, or procedure. It is the method by which fully informed, rational persons may be involved in choices about their health care.

Description

Informed consent stems from the legal and ethical right an individual has to decide what is done to his or her body, and from the physician's ethical duty to make sure that individuals are involved in decisions about their own health care. The process of securing informed consent has three phases, all of which involve information exchange between doctor and patient and are part of patient education. First, in words an individual can understand, the physician must convey the details of a planned procedure or treatment, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of the treatment. Second, the physician must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the procedure or treatment with full knowledge and forethought. Finally, the individual must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies.

It is critical that a patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way. It is the responsibility of the physician who discusses the particulars with the patient to detail the conversation in the medical record. A physician may, at his or her discretion, appoint another member of the health care team to obtain the patient's signature on the consent form, with the assurance that the physician has satisfied the requirements of informed consent.

The law requires that a reasonable physician/patient standard be applied when determining how much information is considered adequate when discussing a procedure or treatment with the patient. There are three approaches to making this discussion: what the typical physician would say about the intervention (the reasonable physician standard); what an average patient would need to know to be an informed participant in the decision (the reasonable patient standard); and what a patient would need to know and understand to make a decision that is informed (the subjective standard).

There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. At the war crimes tribunal in 1949, 10 standards were put forth regarding physicians' requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post-WW II human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology of disease, and for studies performed that avoided physical and mental suffering to the fullest extent possible.

Today, all of the 50 United States have legislation that delineates the required standards for informed consent. For example, the State of Washington employs the second approach outlined as the reasonable patient standard (what an average patient would need to know to be an informed participant in the decision). This approach ensures that a doctor fulfills all professional responsibilities and provides the best care possible and that patients have choices in decisions about their health care. However, the patient's competence in making a decision is considered. This points to the issue of the patient's mental capacity. Anyone suffering from an illness, anticipating surgery, or undergoing treatment for a disease is under a great deal of stress and anxiety. It may be natural for a patient to be confused or indecisive. When the attending physician has serious doubts about the patient's understanding of the intervention and its risks, the patient may be referred for a psychiatric consultation. This is strictly a precaution to ensure that the patient understands what has been explained; declining to be treated or operated on does not necessarily mean the person is incompetent. It could mean that the person is exercising the right to make his or her own health care decisions.

Although the law requires a formal presentation of the procedure or treatment to the patient, physicians do express doubt as to the wisdom of this. Some believe that informing patients of the risks of treatment might scare them into refusing it, even when the risks of non-treatment are even greater. But patients might have a different view. Without the complete story, for example, a patient might consent to beginning a particular course of chemotherapy. Convinced by the pressures from a pharmaceutical company, it is conceivable that a doctor will use an agent less effective than a newer treatment. By withholding information about treatment alternatives, the physician may be denying the patient a choice and, worse, perhaps a chance of an extended life of greater quality.

Undeniably, physicians in surgery, anesthesia, oncology, infectious disease, and other specialties are faced with issues regarding informed consent. As the federal government takes a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled, more and more health care providers must become educated in what must be conveyed to patients. This is emphasized by the report of a case in which a federal court (Hutchinson vs. United States [91 F2d 560 (9th Cir. 1990)]) ruled in favor of the physician, despite his failure to advise his asthmatic patient, for whom he had prescribed the steroid, prednisone, of the drug's well-known risk of developing aseptic necrosis (bone death), which did occur. The practitioner neglected to inform the patient that there were other drugs available with much less serious side effects that could have treated the asthma. However, a higher appellate court reversed the ruling and found the physician guilty. Apparently, the patient had used more conservative drugs in the past with good results. The court believed that if the physician had merely advised the patient of the more serious side effects of prednisone and offered the patient more conservative treatment, the physician would have avoided liability.

Nursing professionals have a greater role than they might believe in evaluating whether or not consent is informed. When a nurse witnesses the signature of a patient for a procedure, or surgery, he or she is not responsible for providing the details. Rather, the role is to be the patient's advocate, to protect the patient's dignity, to identify any fears, and to determine the patient's degree of comprehension and approval of care to be received. Each patient is an individual, and each one will have a different and unique response depending on his or her personality, level of education, emotions, and cognitive status. If a patient can restate the information that has been imparted, then that will help to confirm that he or she has received enough information and has understood it. The nurse is obligated to report any doubts about the patient's understanding regarding what has been said or any concerns about his or her capacity to make decisions.

Results

The result of informed consent is greater safety and protection for patients, physicians, and society.

See also
Do not resuscitate order;
Patient confidentiality;
Patient rights.

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Informed Consent

Encyclopedia of Public Health
COPYRIGHT 2002 The Gale Group Inc.

INFORMED CONSENT

The concept of informed consent originated with the recognition of individuals' rights to freedom and human dignity. People reduced to conditions of slavery were subjected without their consent to interferences with their freedom. Children and other dependent persons may also be treated in ways to which they do not consent, but those responsible for their care, such as parents or other legal guardians, are bound by ethical and legal limits in the procedures they can authorize.

ETHICAL ORIGIN

The ethical principle of respect for autonomy requires that people capable of responsible independence should not be subjected to others' interventions with their bodily freedom or comfort unless they have consented in advance. Similarly, autonomous people who consent to a procedure that affects them should not be liable to another person's veto or prohibition because the other person considers the procedure to be not in their best interests.

Consent has particular significance concerning health care, because medical or other health care interventions can affect persons' bodies, comfort, and lives in very invasive and irreversible or long-lasting ways. public health initiatives designed to protect or promote the health of individuals as members of population groups or residents of communities can also be intrusive and long-lasting, but consent is often given to these through political or democratic means, such as by legislation permitting inspection of health records to find the incidence and prevalence of preventable diseases. However, some public health strategies, such as vaccination programs, affect individuals so personally that their own consent, or that of their legal guardians, is required before procedures can be undertaken on them.

CONSENT IN LAW

In law, the physical touching of a person's body without authorization or consent is an offense, often called assault in criminal law and battery in civil law directed toward compensation. The person's consent to the touching neutralizes or removes the offense. Consent is an important concept in medical and related health care. Health care personnel act unethically, unprofessionally, and illegally if they directly interfere with a person's body without consent by undertaking unauthorized procedures on the person, exceeding consent the person has given, or performing procedures different from those the person has approved. Consent is often spoken in deliberate language, and for more invasive procedures such as surgery and for research procedures may have to be given or confirmed in writing. For minor procedures, however, consent may be implied by a person's behavior, for example, by consciously permitting an intervention such as vaccination or blood-drawing to occur. Further, because in law "peril invites rescue," emergency interventions when life or enduring health are endangered are considered to have implied consent if they are reasonable under the circumstances.

INFORMED CONSENT

Law and ethics sometimes require more than compliance alone to render an intervention acceptable. The consent must be adequately informed for it to satisfy legal and ethical standards. In medical care law, consent continues to remove liability for assault and battery, but the physician or other care provider has a legal duty to ensure that the person whose consent is required receives information that is material to the choice whether or not to consent. Reasonable efforts must also be made to ensure that the person understands the information to his or her satisfaction. Failure to provide adequate information to a person deciding whether to consent to a proposed intervention or to refuse it constitutes legal negligence when injury results, often called malpractice. This is so even when no assault and battery occurs because the person refuses treatment. "Informed consent" includes informed dissent and is better understood as informed choice or informed decision-making.

ELEMENTS OF INFORMED CONSENT

Whether or not to consent to proposed medical treatment is not itself a medical decision. It is a personal decision that someone makes when adequately informed of medical and nonmedical options and their relevant implications. Health care providers do not have to explain all the physiological, biological, pharmaceutical, and other processes that constitute the procedures among which the person may choose. But they must distill the elements the person will want to understand in order to exercise judgment about what will best serve his or her interests and preserve or promote personal values and goals. For instance, the effect of prospective treatments on capacity to work is often important. A person intending to have a child must understand the impact of treatment options on future fertility and child-rearing. A person who devoutly feels that life must be preserved to the last possible moment must be informed whether a treatment will lead to or risk earlier loss, and a person fearful of pain should be informed whether and how future comfort can be provided.

Accordingly, information must focus on the sort of individual the decision-maker is. This cannot usually be known in intimate detail and must initially be based on a representative reasonable or prudent person in the decision-maker's circumstances. Information may be amplified in light of the person's response, particularly the questions the person asks on initial receipt of information. Informing is often best regarded not as a single event but rather as a continuing process that begins with the provider asking the decision-maker questions about lifestyle, preferences, and intentions in order to direct information toward his or her needs, give information and explanation to serve such needs, answer uncertainties and questions the decision-maker has, and supply material information throughout the course of treatment.

Items to be addressed usually include:

Implications of going without treatment and of treatment being postponed for different periods

The range of accessible diagnostic or treatment options

The extent of public or private insurance coverage for each option and costs patients would personally incur

The benefits each option offers

The possibilities of diagnostic false results or treatment failures

The risks and discomforts of diagnostic or treatment options even when successful

The more invasive or risk-laden a procedure, the more information should be provided. For the low-risk procedure of blood-sampling, for instance, disclosure of liability to sudden pain, bruising, and easily treated infection is usually adequate in itself, with greater information given about why sampling is proposed and what it may show.

COLLECTIVE OR GROUP CONSENT

Consent is usually requested from individuals proposed to be physically affected by health care procedures, but some decisions justify collective or group consent, such as fluoridation of a municipal drinking water supply. Information is made available, for instance, to democratically elected representatives authorized to make decisions on behalf of local residents. Community hospitals' decisions on what services to offer and what types of equipment to purchase are made by hospitals' boards of governors or trustees. Governors or trustees may be appointed by governments, but are often elected from among residents of areas the hospitals serve who choose to become members of the hospital associations. The decisions affect the water local residents consume and the health services they may receive, but individual consent is replaced by democratic or otherwise political consent. In some communities, hereditary or traditional leaders who make decisions with the permission of those they govern can consent to public health measures. Hereditary or traditional authority to make decisions affecting such groups is legitimate when groups' members identify themselves with each other and acknowledge an internal group structure and hierarchy that appoints chiefs or leaders. However, consent from such leaders to public health programs does not compel individuals to give their consent to personally invasive procedures such as vaccination. When group members do not possess a sense of community with each other but simply meet criteria of a particular study, such as on the effects of giving different dietary combinations to hospitalized single or widowed women aged 65 to 75, there is no representative group member with authority to make decisions on behalf of others.

REFUSAL OF INFORMATION

Competent persons have the autonomous right to consent without information. They have the right, not the duty, to receive information. They must state their preferences for overall care, but they may forgo detailed information that health-service providers prepare to offer. Providers incur no liability for risks that patients freely assume by refusal of offered information.

Bernard M. Dickens

(see also: Autonomy; Beneficence; Codes of Conduct and Ethics Guidelines; Ethics of Public Health; Nonmaleficence; Paternalism; Public Health and the Law )

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Informed consent

Informed consent

Definition

Informed consent is a legal document in all 50 states, prepared as an agreement for treatment, non-treatment, or for an invasive procedure that requires physicians to
disclose the benefits, risks, and alternatives to the treatment, non-treatment, or procedure. It is the method by which a fully informed, rational patient may be involved in the choices about his or her health. Informed consent applies to mental health practitioners (psychiatrists, psychologists, etc.) in their treatment with their clients in generally the same way as physicians with their patients.

Description

Informed consent stems from the legal and ethical right the patient has to decide what is done to his or her body, and from the mental health provider's ethical duty to ensure that the patient is involved in decisions about his or her own health care. The process of ensuring informed consent for treatment involves three phases, all of which involve information exchange between doctor and patient and are a part of patient education. First, in words the patient can understand, the therapist must convey the details of a treatment or procedure, its potential benefits and serious risks, and any feasible alternatives. The patient should be presented with information on the most likely outcomes of treatment. Second the practitioner must evaluate whether or not the person has understood what has been said, must ascertain that the risks have been accepted, and that the patient is giving consent to proceed with the treatment with full knowledge and forethought. Finally, the patient must sign the consent form, which documents in generic format the major points of consideration. The only exception to this is securing informed consent during extreme emergencies. It is critical that the patient receive enough information on which to base informed consent, and that the consent is wholly voluntary and has not been forced in any way.

According to the Ethical Principles of Psychologists and Code of Conduct designed by the American Psychological Association, informed consent also applies when conducting research involving human subjects prior to their participation. Participants in the study should be informed in understandable language to three main points. First, the participant should be informed about the nature of the research. Secondly, participants should be informed that their participation is completely voluntary and that they are free to withdraw from or not participate in the study at any time. Consent must be made without pressure being put on the participant to engage in the study. Finally, the potential consequences of participating or withdrawing should be presented to the participant. This includes risks, discomfort, and limitations of confidentiality.

With regard to either therapy treatment or research participation, another member of the health care/research team may obtain the signed informed consent with the assurance that the provider has satisfied the requirements of informed consent.

The actual informed consent form is to document the process and protect the provider and the hospital. Legally, it is proof that things have been covered and the patient agrees to the procedure, risks, benefits, options, etc. The informed consent process is in place for the protection of the patient. The process is in place to ensure that everything is discussed with the patient: all of the options, all of the common risks, the worst case scenario, and other similar situations.

Viewpoints

There is a theory that the practice of acquiring informed consent is rooted in the post-World War II Nuremberg Trials. Following the war crimes tribunal in 1949, as a result of the Kaarl Brandt case, 10 standards were put forth regarding physician's requirements for experimentation on human subjects. This established a new standard of ethical medical behavior for the post-WW II human rights age, and the concept of voluntary informed consent was established. A number of rules accompanied voluntary informed consent within the realms of research. It could only be requested for experimentation for the gain of society, for the potential acquisition of knowledge of the pathology, and for studies performed that avoided physical and mental suffering to the fullest extent possible..

A crucial component of informed consent is that the person signing it is competent or able to make a rational decision and meaningfully give consent. This situation gets more complicated when working with people who are unable to understand what has been explained or are unable to make a reasonable decision about their health care. According to the Code of Conduct for Psychologists designed by the American Psychological Association, if this is the case, informed permission from a "legally authorized person" should then be sought, if that is a legal alternative. The ethical guidelines are more stringent than legal guidelines in many states, where the informed consent of the parent or guardian is all that is required, whether or not the professional has attempted to explain the procedure to the client.

Although it is necessary to present the procedure or treatment formally to the patient, there is concern that this process could hurt the therapeutic relationship between the client and therapist. For example, if an informed consent is too detailed, it could frighten a new client who may be hesitant about therapy to begin with. In addition, informing patients about the risks of treatment might scare them into refusing it when the risks of non-treatment are even greater. There are however,
advantages to the informed consent process. First, it can be empowering to the patient to understand that he/she plays an important role in their own treatment. They are encouraged to be active participants in the treatment process and know their options well enough to make the best treatment decisions for themselves. This also shifts the responsibility to patients to work with the therapist towards their mental health goals, possibly increasing self-confidence and autonomy, and decreasing dependence on the therapist.

Professional implications

There are undoubtedly many issues regarding Informed Consent. As modern society continues to be litigious, the courts and/or government may take on a more active role in deciding the extent to which patients must be informed of treatments, procedures, and clinical trials in which they voluntarily become enrolled. Therefore, health care providers must become more educated as to what needs to be conveyed to patients, and to what extent.

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Informed Consent

Informed Consent

The term research refers to a systematic investigation designed to develop or contribute to generalizable knowledge by testing and proving or disproving specific hypotheses. The knowledge gained through research may be important as a basis for the formulation of social policy or the improvement of practice in medicine, education, social services, or other areas. Research may produce information as the result of experimentation that involves introducing some new variable (e.g., a test drug or method of treatment) into the situation and seeing what difference, if any, that new variable makes. Alternatively, research may entail gathering data and drawing conclusions by observing things happening naturally (i.e., a natural experiment). In both the experimental and observational methods, research may involve using human beings as participants who serve as the sources of data from which the generalizable conclusions are drawn. Especially when human participants are involved, research must be conducted in an ethical manner, including assurances that the participants have given informed consent for their involvement.

Principles regarding the proper conduct of research involving human participants have been incorporated into over thirty different international guidelines and ethical codes. The first of these was the Nuremberg Code, adopted in 1947 for Nazi war-crime trials in which defendant physicians tried to justify their horrible actions as scientific experiments. Subsequent ones were spurred on by various scandals involving the mistreatment of human subjects, such as the forty-year Tuskegee (Non-Treatment of) Syphilis Study, the deliberate hepatitis infection of residents at Willowbrook (New York) state hospital between 1956 and 1971, and injection of live cancer cells into patients in 1963 at the Jewish Chronic Disease Hospital in Brooklyn, New York. In the United States, Congress in 1974 enacted the National Research Act, establishing the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (popularly referred to as the Belmont Commission ). In 1981 regulations embodying some of the Belmont Commission’s recommendations were issued by the federal Department of Health and Human Services (DHHS, but at the time called the Department of Health, Education, and Welfare). These regulations have been adopted by other federal agencies as a Common Rule to protect human participants in any research protocol those agencies sponsor. Also, any research concerning the testing of investigational drugs or medical devices is regulated simultaneously by the federal Food and Drug Administration (FDA).

Research to which these regulations apply must be reviewed and approved by an interdisciplinary Institutional Review Board (IRB) and is subject to continuing IRB oversight. Conducting a research protocol without IRB approval or over IRB objection subjects the investigator and sponsoring institution to the loss of any future government funding for the conduct of research.

For any proposed research protocol, the IRB must ensure (among other things) that informed consent will be obtained from each potential participant. Potential participants must be informed of the following:

the purposes of the research, its expected duration, and the procedures involved;

anticipated risks or discomforts, as well as benefits, of participation and all reasonable alternatives to participation in the research protocol;

the extent to which research records will be kept confidential;

the availability of any compensation and/or treatment for research-related injuries;

the right not to participate and to discontinue participation at any time without penalty.

The IRB also must ensure that participants’ informed consent is appropriately documented.

The IRB must police the requirement that no human subject is involved in research unless ethically sufficient informed consent has been obtained and the prospective participant has had the chance, without coercion or undue influence (i.e., voluntarily), to really consider whether or not to participate. The regulatory provisions for informed consent in research are basically a codification and extension of the common law (i.e., the judge-made law that evolves on a case-by-case basis) in the diagnostic and therapeutic setting. Under the common law, valid consent requires that the individual’s agreement be voluntary, informed, and given by a person with adequate cognitive and emotional capacity. Individual IRBs are themselves monitored by the Office for Human Research Protections within DHHS.

Some states have enacted their own, additional laws, which vary quite a bit, concerning conditions for protection of research subjects. Moreover, private civil malpractice lawsuits may be brought by an individual participant against researchers and protocol sponsors for violation of common law standards regarding the obtaining of informed consent or other deviations from the acceptable standard of care under the circumstances.

Ethical researchers owe a heightened obligation to make certain that meaningful informed consent has been obtained for research involving especially vulnerable participants, particularly when the research consists of risky experimental interventions. Especially vulnerable persons in this context include persons with mental disabilities that impair decision-making capacity, prisoners, children, and pregnant women. Racial factors must also be taken into account when considering the need for special protections for vulnerable groups, because it has been common historically for researchers to both take undue advantage of members of racial minority groups by including them disproportionately in very risky studies, and to deny them the potential benefits of research participation by unfairly excluding them from certain studies. When a potential research participant is unable to give valid voluntary, informed consent personally, a surrogate acting on behalf of the person’s best interests may act as decision-maker.

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Informed Consent

West's Encyclopedia of American Law
COPYRIGHT 2005 The Gale Group, Inc.

INFORMED CONSENT

Assent to permit an occurrence, such as surgery, that is based on a complete disclosure of facts needed to make the decision intelligently, such as knowledge of the risks entailed or alternatives.

The name for a fundamental principle of law that a physician has a duty to reveal what a reasonably prudent physician in the medical community employing reasonable care would reveal to a patient as to whatever reasonably foreseeable risks of harm might result from a proposed course of treatment. This disclosure must be afforded so that a patient—exercising ordinary care for his or her own welfare and confronted with a choice of undergoing the proposed treatment, alternative treatment, or none at all—can intelligently exercise judgment by reasonablybalancingthe probable risks against the probable benefits.

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informed consent

The Columbia Encyclopedia, 6th ed.

Copyright The Columbia University Press

informed consent, in medicine, a patient's written consent to a surgical or medical procedure or other course of treatment, given after the physician has told the patient all of the potential benefits, risks, and alternatives involved. Informed consent is also required for participation in clinical studies. The concept of informed consent is based on the principle that a physician has a duty to disclose to a patient information that allows the patient to make a reasonable decision regarding his or her own treatment. There is debate over whether special populations, such as children and the mentally ill, can really be considered to have given informed consent.

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informed consent

informed consent (in-formd) n. the principle that determines the amount of information to be disclosed by clinicians or researchers to patients undergoing surgery or invasive tests or to subjects involved in a clinical trial in order to render their consent lawful. See consent.

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